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Recall Observatory FDA recall evidence

Device product

RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.

Z-0038-2015

September 03, 2014

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 69104
Status
Terminated
Classification
Class II
Quantity
875 units
Official record key
device-enforcement:Z-0038-2015

Official wording

Reason: Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.

Code information: J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586, NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023, 578910, 578913, R578910, R578912, R578913, 582631, and 592125.

Distribution pattern: Worldwide Distribution -- USA, including the states of ME, MD, PA, MA, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, NC, VA, NY, TN, and IN; and, the countries of Canada, Australia, Austria, Belgium, Czech Republic, United Kingdom, France, Germany, Ireland, Israel, New Zealand, Norway, Poland, Slovenia, South Africa, Switzerland, and Chile.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.